Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 April 2013 (Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2013-05-31
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2013154EN.01000101.xml










31.5.2013   


EN


Official Journal of the European Union


C 154/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 April 2013

(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
 (1)
)

2013/C 154/01
—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted













Date of the decision


Name of the medicinal product


INN (International Non-Proprietary Name)


Holder of the marketing authorization


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




17.4.2013


Hexacima


Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)







Sanofi Pasteur SA




2 avenue Pont Pasteur, F-69007 Lyon, France






EU/1/13/828


Suspension for injection


J07CA09


19.4.2013




17.4.2013


Hexyon


diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)







Sanofi Pasteur MSD, SNC




8 rue Jonas Salk, F-69007 Lyon, France






EU/1/13/829


Suspension for injection


J07CA09


19.4.2013




17.4.2013


Imatinib Actavis


Imatinib







Actavis Group PTC ehf.




Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland






EU/1/13/825


Capsule, hard
Film-coated tablet


L01XE01


19.4.2013




22.4.2013


Memantine LEK


Memantine







Pharmathen S.A.




6 Dervenakion, 15351 Pallini Attiki, Ελλάδα






EU/1/13/826


Film-coated tablet


N06DX01


24.4.2013




22.4.2013


Memantine Mylan


Memantine







Generics [UK] Limited




Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom






EU/1/13/827


Film-coated tablet


N06DX01


24.4.2013




22.4.2013


Nemdatine


Memantine







Actavis Group PTC ehf.




Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland






EU/1/13/824


Film-coated tablet


N06DX01


24.4.2013




29.4.2013


Maruxa


Memantine







Krka, d. d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/13/820


Film-coated tablet


N06DX01


6.5.2013







—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted










Date of the decision


Name of the medicinal product


Holder of the marketing authorization


Number of the entry in the Community Register


Date of notification




9.4.2013


NULOJIX







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom






EU/1/11/694


11.4.2013




9.4.2013


Oprymea







Krka, d. d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/08/469


11.4.2013




9.4.2013


Thalidomide Celgene







Celgene Europe Limited




1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom






EU/1/08/443


11.4.2013




9.4.2013


Xiapex







Auxilium UK Limited




Orchard Lea, Winkfield Lane, Windsor, Berks SL4 4RU, United Kingdom






EU/1/11/671


11.4.2013




10.4.2013


Rasitrio







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/11/730


12.4.2013




17.4.2013


Competact







Takeda Pharma A/S




Langebjerg 1, DK-4000 Roskilde, Danmark






EU/1/06/354


19.4.2013




17.4.2013


Doribax







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/08/467


19.4.2013




17.4.2013


Rasilez







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/07/405


19.4.2013




17.4.2013


Rasilez HCT







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/08/491


19.4.2013




17.4.2013


Rivastigmine Actavis







Actavis Group PTC ehf.




Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland






EU/1/11/693


19.4.2013




17.4.2013


Tyverb







Glaxo Group Limited




Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/07/440


19.4.2013




17.4.2013


Viagra







Pfizer Limited




Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom






EU/1/98/077


19.4.2013




22.4.2013


Emselex







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/04/294


24.4.2013




22.4.2013


Incivo







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/11/720


24.4.2013




22.4.2013


INCRELEX







Ipsen Pharma




65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France






EU/1/07/402


24.4.2013




22.4.2013


Jentadueto







Boehringer Ingelheim International GmbH




Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland






EU/1/12/780


24.4.2013




22.4.2013


Mabthera







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/98/067


24.4.2013




22.4.2013


Rasilamlo







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/11/686


24.4.2013




22.4.2013


Tandemact







Takeda Pharma A/S




Langebjerg 1, DK-4000 Roskilde, Danmark






EU/1/06/366


24.4.2013




22.4.2013


Trajenta







Boehringer Ingelheim International GmbH




Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland






EU/1/11/707


24.4.2013




22.4.2013


Vedrop







Orphan Europe S.A.R.L.




Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France






EU/1/09/533


24.4.2013




29.4.2013


Actos







Takeda Pharma A/S




Langebjerg 1, DK-4000 Roskilde, Danmark






EU/1/00/150


1.5.2013




29.4.2013


Glubrava







Takeda Pharma A/S




Langebjerg 1, DK-4000 Roskilde, Danmark






EU/1/07/421


1.5.2013




29.4.2013


Glustin







Takeda Pharma A/S




Langebjerg 1, DK-4000 Roskilde, Danmark






EU/1/00/151


1.5.2013




29.4.2013


Soliris







Alexion Europe SAS




25 boulevard de l'Amiral Bruix, F-75016 Paris, France






EU/1/07/393


2.5.2013




29.4.2013


Stocrin







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/99/111


1.5.2013




29.4.2013


Sustiva







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom






EU/1/99/110


1.5.2013




29.4.2013


Viread







Gilead Sciences International Limited




Cambridge CB21 6GT, United Kingdom






EU/1/01/200


1.5.2013







—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)










Date of the decision


Name of the medicinal product


Holder of the marketing authorization


Number of the entry in the Community Register


Date of notification




10.4.2013


Pelzont







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/08/460


12.4.2013




10.4.2013


Tredaptive







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/08/459


12.4.2013




10.4.2013


Trevaclyn







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/08/458


12.4.2013







—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
 (2)
): Accepted













Date of the Décision


Name of the medicinal product


INN (International Non-Proprietary Name)


Holder of the marketing authorization


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




10.4.2013


ECOPORC SHIGA


Genetically modified recombinant Stx2e antigen







IDT Biologika GmbH




Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland






EU/2/13/149


Suspension for injection


QI09AB02


12.4.2013




22.4.2013


Meloxidolor


Meloxicam







Le Vet Beheer B.V.




Wilgenweg 7, NL-3421 TV Oudewater, Nederland






EU/2/13/148


Solution for injection


QM01AC06


24.4.2013







—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted










Date of the decision


Name of the medicinal product


Holder of the marketing authorization


Number of the entry in the Community Register


Date of notification




10.4.2013


Equilis Prequenza Te







Intervet International B.V.




Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland






EU/2/05/057


12.4.2013




Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:





The European Medicines Agency




7, Westferry Circus,




Canary Wharf




UK-LONDON E14 4H






(1)  OJ L 136, 30.4.2004, p. 1.

(2)  OJ L 136, 30.4.2004, p. 1.